Study of AT-752 in Healthy Subjects

NCT ID: NCT04722627

Last Updated: 2022-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-09

Study Completion Date

2021-11-14

Brief Summary

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This study will assess the safety, tolerability and pharmacokinetics (PK) of AT-752 in healthy subjects

Detailed Description

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A First-in Human, Randomized, Double-blind, Placebo controlled Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of AT-752 in Healthy Subjects

Conditions

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Dengue

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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AT-752 250 mg single dose

AT-752 administered orally, 250 mg on Day 1

Group Type EXPERIMENTAL

AT-752

Intervention Type DRUG

Parallel Assignment

Placebo -single dose

Matching placebo administered orally on Day 1

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Parallel Assignment

AT-752 500 mg single dose

AT-752 administered orally, 500 mg single doses on Day 1 and Day 7

Group Type EXPERIMENTAL

AT-752

Intervention Type DRUG

Parallel Assignment

Placebo- single dose

Matching placebo administered orally on Day 1 and Day 7

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Parallel Assignment

AT-752 1000 mg single dose

AT-752 administered orally, 1000 mg single dose on Day 1

Group Type EXPERIMENTAL

AT-752

Intervention Type DRUG

Parallel Assignment

Placebo - single dose

Matching placebo administered orally on Day 1

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Parallel Assignment

AT-752 1500 mg single dose

AT-752 administered orally, 1500 mg single dose on Day 1

Group Type EXPERIMENTAL

AT-752

Intervention Type DRUG

Parallel Assignment

Placebo: single dose

Matching placebo administered orally on Day 1

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Parallel Assignment

AT-752 - 1000 mg QD multiple doses

AT-752 - administered orally, 1000 mg once daily (QD) for 7 days

Group Type EXPERIMENTAL

AT-752

Intervention Type DRUG

Parallel Assignment

Placebo - Administered once daily (QD)

Matching placebo administered orally once daily (QD) for 7 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Parallel Assignment

AT-752 - 750 mg twice daily (BID)

AT-752 administered orally, 750 mg twice daily (BID) for 4 days plus one dose on Day 5.

Group Type EXPERIMENTAL

AT-752

Intervention Type DRUG

Parallel Assignment

Placebo - Administered twice daily (BID)

Matching placebo administered orally twice daily (BID) for 4 days plus one dose on Day 5.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Parallel Assignment

AT-752 - 750 mg three times daily (TID)

AT-752 administered orally, 750 mg three times daily (TID) for 4 days plus one dose on Day 5.

Group Type EXPERIMENTAL

AT-752

Intervention Type DRUG

Parallel Assignment

Placebo - Administered TID

Matching placebo administered orally (TID) for 4 days plus one dose on Day 5.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Parallel Assignment

Interventions

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AT-752

Parallel Assignment

Intervention Type DRUG

Placebo

Parallel Assignment

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Body mass index (BMI) of 18-29 kg/m2
2. Must agree to use protocol-specified methods of contraception
3. Negative pregnancy test
4. Willing to comply with the study requirements and to provide written informed consent

Exclusion Criteria

1. Pregnant or breastfeeding
2. Abuse of alcohol or drugs
3. Use of other investigational drugs within 30 days of dosing
4. Other clinically significant medical conditions
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Atea Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Atea Study Site

Melbourne, Victoria, Australia

Site Status

Countries

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Australia

References

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Zhou X-J, Lickliter J, Montrond M, Ishak L, Pietropaolo K, James D, Belanger B, Horga A, Hammond J. First-in-human trial evaluating safety and pharmacokinetics of AT-752, a novel nucleotide prodrug with pan-serotype activity against dengue virus. Antimicrob Agents Chemother. 2024 May 2;68(5):e0161523. doi: 10.1128/aac.01615-23. Epub 2024 Mar 25.

Reference Type DERIVED
PMID: 38526047 (View on PubMed)

Other Identifiers

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AT-02A-001

Identifier Type: -

Identifier Source: org_study_id

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